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Prospective Observational Epidemiologic Study of Maraviroc's Safety (POEM)

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ClinicalTrials.gov Identifier: NCT00665561
Recruitment Status : Active, not recruiting
First Posted : April 24, 2008
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Drug: Maraviroc along with an optimized background antiretroviral drug regimen Drug: Optimized background antiretroviral drug regimen without maraviroc

Detailed Description:
All patients meeting the study eligibility criteria at participating sites will be invited to participate.

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 2454 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-experienced Hiv-1 Infected Patients
Actual Study Start Date : March 31, 2008
Estimated Primary Completion Date : February 26, 2019
Estimated Study Completion Date : February 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Maraviroc exposed Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Maraviroc prescribed per approved local label.
Other Name: Selzentry, Celsentri
Maraviroc unexposed Drug: Optimized background antiretroviral drug regimen without maraviroc
Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths [ Time Frame: Followed till 6 months after drug discontinuation up to a total of 5 years. ]
  2. All Malignancies (AIDS defining and non-AIDS defining), Myocardial ischemia or infarction, All cause mortality [ Time Frame: Followed for a total of up to 5 years regardless of the time of drug discontinuaion. ]

Secondary Outcome Measures :
  1. There are no Secondary Outcomes for this study. [ Time Frame: 0 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Treatment experienced, HIV-1 infected patients in routine clinical practice.
Criteria

Inclusion Criteria:

  • Treatment experienced, HIV-1 infected patients
  • 18 years or older
  • Receive an approved assay for determination of HIV-1 tropism

Exclusion Criteria:

  • Pregnant or lactating
  • Using CCR5 inhibitor other than maraviroc
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665561


  Show 267 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00665561     History of Changes
Other Study ID Numbers: A4001067
2007-006148-24 ( EudraCT Number )
POEM ( Other Identifier: Alias Study Number )
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by ViiV Healthcare:
Maraviroc
HIV-1
Safety
Non-interventional

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Slow Virus Diseases
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents